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Medicines/Pharmaceuticals of Animal Origin V3.0 November 2020

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Medicines/Pharmaceuticals of Animal Origin V3.0 November 2020 Medicines/pharmaceuticals of animal origin V3.0 November 2020 Medicines/pharmaceuticals of animal origin - This guideline provides information for all clinical staff within Hospital and Health Services (HHS) on best practice for avoidance of issues related to animal products. Medicines/pharmaceuticals of animal origin - V3.0 November 2020 Published by the State of Queensland (Queensland Health), November 2020 This document is licensed under a Creative Commons Attribution 3.0 Australia licence. To view a copy of this licence, visit creativecommons.org/licenses/by/3.0/au © State of Queensland (Queensland Health) 2020 You are free to copy, communicate and adapt the work, as long as you attribute the State of Queensland (Queensland Health). For more information contact: Medication Services Queensland, Queensland Health, GPO Box 48, Brisbane QLD 4001, email [email protected] An electronic version of this document is available at https://www.health.qld.gov.au/__data/assets/pdf_file/0024/147507/qh-gdl-954.pdf Disclaimer: The content presented in this publication is distributed by the Queensland Government as an information source only. The State of Queensland makes no statements, representations or warranties about the accuracy, completeness or reliability of any information contained in this publication. The State of Queensland disclaims all responsibility and all liability (including without limitation for liability in negligence) for all expenses, losses, damages and costs you might incur as a result of the information being inaccurate or incomplete in any way, and for any reason reliance was placed on such information. Medicines/pharmaceuticals of animal origin - V3.0 November 2020 Page 2 Table of Contents 1 Purpose 4 2 Scope 4 3 Background 4 4 Religious restrictions 5 4.1 Organisations consulted: 7 5 Resources 7 6 Appendices 9 Appendix A - Porcine (Pig) products 9 Appendix B - Bovine (Cow) products 11 Bovine – Manufacture includes exposure to bovine materials “Bovine-Indirect 14 Appendix C Chinese Hamster Ovary (CHO) cells 17 Appendix D - Murine (mouse) 21 Appendix E - Equine (Horse) 25 Appendix F - Egg/Chicken 26 Appendix G – Other Animals 29 Appendix H - Excipients that may be of animal origin 31 7 References 32 8 Approval 33 9 Version Control 33 Medicines/pharmaceuticals of animal origin - V3.0 November 2020 Page 3 1 Purpose This guideline provides information for clinicians to assist patients wishing to avoid animal product, to make informed decisions about their treatment/care. 2 Scope People with food allergies or intolerances, or who want to avoid animal products for religious, cultural or secular reasons may want to know about the origin/source of drugs and excipients contained within their medicines, to enable them to make a fully informed decision about their treatment. This wish is supported by the Australian Charter of Healthcare Rights which states that ‘patients have a right to have their culture, identity, beliefs and choices recognised and respected’. This document provides information for clinicians to assist patients in making this choice. This guideline provides information for all clinicians involved in the medicines management cycle within Hospital and Health Services (HHS). While the information contained in the tables of products in the appendices is compiled from the best information available, it should not be regarded as fully comprehensive. Information on enteral and infant feeds (and many herbal and complimentary medicines) is not included in this document. Please refer to a dietitian for advice on enteral/infant feed composition. 3 Background Person-centred care is the gold standard approach to healthcare delivery and has been shown to improve the safety and quality of health care, improve patient outcomes and experience, and improve the performance of health service organisations1. For this reason, healthcare professionals must take into consideration patients’ patients’ religious beliefs and lifestyles when prescribing and administering medicines.2 Many different medicines and vaccines, or specific formulations of a medicine such as tablets, capsules, creams or mixtures contain animal products or are animal derived. For example, gelatin is a partially hydrolysed collagen which is usually bovine (beef) or porcine (pig) in origin. Gelatin is used in making capsule shells and is one of many types of stabilisers added to pharmaceutical products such as vaccines.3 Heparin, an injectable anticoagulant, is prepared from a porcine source. Further examples of pharmaceutical products known to be of animal origin are listed in the appendices Several of the world’s most prominent religions have objected to the use of certain animal- derived products, including Muslim, Hindu, Christian, Jewish and Buddhist faiths (see table 1). A growing number of individuals are also increasingly restricting their consumption and use of animal-derived products for ethical reasons such as animal welfare and objections to the intentional killing of animals, environmental concerns and perceived health benefits, However, neither religious nor secular groups are homogeneous in their views on the use of Medicines/pharmaceuticals of animal origin - V3.0 November 2020 Page 4 animal-derived products used in their care. Consequently, there is considerable diversity of opinion, and membership of a particular group does not necessarily dictate an individual’s convictions4. However, informing patients about the origins of their proposed medication (if animal derived and no suitable synthetic alterative exists) will assist them in making informed decisions regarding their treatment.2 There may be provisions within various religious groups to provide some form of dispensation, depending on the nature of the need for treatment. NB All medicines must undergo testing in non-human animals before they can proceed to testing in humans in order to gain a product license13. 4 Religious restrictions Table 1 Religious restrictions Countries where widely Religion practiced (relevant to Restrictions Queensland) Tibet, Bhutan, India, Nepal, Sri Lanka, Burma, Thailand, Laos, For some vegetarian Buddhists - all Buddhism Cambodia, Malaysia, Vietnam, China, animal products prohibited Bangladesh, Korea, Japan, however, no fixed rules. Singapore, parts of Russia. For majority who are vegetarian – India, Nepal, Bangladesh, Indonesia, all animal products including egg Pakistan, Sri Lanka, Philippines, Fiji, prohibited Hinduism UK, Mauritius, Bhutan, South Africa, For those who are not vegetarian, Burma, Singapore restrictions still include bovine* and porcine products Porcine products prohibited Indonesia, India, Pakistan, All animal products not killed in Bangladesh, Egypt, Turkey, Iran, the prescribed ritualistic way Nigeria, Ethiopia, Afghanistan, (halal) prohibited Islam Sudan, Iraq, Malaysia, Tanzania, Products containing alcohol Somalia, Cote d’Ivoire, Congo, prohibited Philippines, Sierra Leone, Thailand, Please note gelatin is Eritrea, Lebanon contentious** Medicines/pharmaceuticals of animal origin - V3.0 November 2020 Page 5 Countries where widely Religion practiced (relevant to Restrictions Queensland) Jehovah’s Abstain from blood products e.g. witnesses blood transfusions. [The use of fractions derived from the A 24 hours a day primary components of blood is not service for absolutely prohibited see – religious and clinicians treating ethical position medical therapy] Jehovah’s Australia, USA, Mexico, Brazil and Witnesses is many other countries (240 in total) Queensland Blood Management available. The number can be provide information on consent found via the and refusal see: consent-refusal ‘Contacts’ Button on their site Many HHSs have procedures for refusal of blood products. All porcine and shellfish products prohibited Other rules about animal products that can be ingested: • land animals must be mammals which chew their cud and have cloven hooves USA, Israel, France, Canada, UK, • Judaism Russia, Argentina, Ukraine, Brazil birds of prey are prohibited and South Africa • fish must have fins and scales • non-fish seafood is prohibited e.g. shellfish • meat and milk (any dairy) cannot be mixed Observers only consume kosher products – complex set of rules Seventh Day Australia, USA, South America, some Some abstain from meat, but eggs Adventist African countries are permissible. For some who are vegetarian – all animal products including egg prohibited For those who are not vegetarian, India, Pakistan, Malaysia, Singapore, restrictions still include bovine and Sikh Fiji, New Zealand, USA and UK porcine products All animal products from halal sources prohibited Products containing alcohol prohibited. Adapted from Multicultural Clinical Support Resource Folder- Health and Religion available at https://www.health.qld.gov.au/__data/assets/pdf_file/0025/158740/8mcrs_hlth_relgn.pdf accessed 03/08/2020 Medicines/pharmaceuticals of animal origin - V3.0 November 2020 Page 6 4.1 Organisations consulted: • Buddhist Council of Queensland (President) • Hindu Society of Queensland (President) • Brisbane Sikh Temple (President) • Seventh-day Adventist Church South Queensland (President) • Jehovah’s witnesses Hospital Information Services International Office • The Islamic Council of Queensland (Secretary) • Vegan Australia • Queensland Jewish Board of Deputies Incorporated 5 Resources A United Kingdom publication titled “Drugs of porcine origin and their clinical alternatives - An introductory guide” 2 (written in 2004, accessed 26/08/2020) gives
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